StrokeNet Thrombectomy Endovascular Platform
STEP
STEP: StrokeNet Thrombectomy Endovascular Platform
2 other identifiers
interventional
1,600
1 country
41
Brief Summary
STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 4, 2024
CompletedStudy Start
First participant enrolled
January 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2030
December 4, 2025
December 1, 2025
4 years
February 13, 2024
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Global disability measured by Modified Rankin Score
The modified Rankin Score is a 7-outcome ordinal scale where 0 = No symptoms and 6= Dead. The analysis of the primary endpoint will be based on a utility weighting of the 7 outcomes, where 0 represents the worst possible health state and 1 represents the best possible state.
90-day
Other Outcomes (5)
Global disability measured by Modified Rankin Score
1 day of hospital discharge
Neurological deficit as measured by the National Institutes of Health Stroke Scale (NIHSS)
24 (+/-12) hours after the time of randomization
Symptomatic intracranial hemorrhage
36 hours after randomization
- +2 more other outcomes
Study Arms (2)
Endovascular Therapy (EVT) Indication Expansion Domain: Low NIHSS Strata
OTHERAdult patients with acute cerebral ischemia within 24 hours of last known well who have large vessel occlusion (LVO) and mild deficits/low NIHSS (NIHSS 0-5) will be randomized to receive one of two strategies: * Endovascular Therapy (EVT) * Medical Management (MM)
Endovascular Therapy (EVT) Indication Expansion Domain: Medium/Distal Occlusions Strata
OTHERAdult patients with acute cerebral ischemia within 24 hours of last known who have Medium Vessel Occlusion (MVO) with Non-dominant/Co-dominant M2 occlusion or Distal Medium Vessel Occlusion (DMVO) patients with M3 occlusion will be randomized to receive one of two strategies: * Endovascular Therapy (EVT) * Medical Management (MM)
Interventions
Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.
Endovascular thrombectomy with any FDA-approved category POL or NRY device - Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (POL), and/or Catheter, Thrombus Retriever (NRY)
Eligibility Criteria
You may qualify if:
- Suspected diagnosis acute ischemic stroke
- Likely causative intracranial large or medium vessel occlusion
You may not qualify if:
- Proven contraindication to endovascular thrombectomy
- Prisoners/incarcerated
- DOMAIN-SPECIFIC ELIGIBILITY CRITERIA:
- Each domain may have additional eligibility criteria.
- \. Age 18 years or older 2. Pre-stroke modified Rankin Scale score 0-2 3. Presentation to enrolling hospital within 24 hours of last known well/stroke onset 4. Able to initiate arterial puncture within 2 hours from qualifying CTA/MRA or CTP/MRP imaging
- \*CT/MR and qualifying CTA/MRA or CTP/MRP should be repeated if more than 120 minutes have elapsed since the imaging and randomization has not been performed. The exception is for LVO Mild deficit/Low NIHSS 0-5 for which imaging would only need to be repeated if there has been significant improvement in the NIHSS prior to randomization.
- \. Has one of the following presentations:
- LVO patients with mild deficits/low NIHSS (must have both):
- Mild presenting neurologic deficits - NIHSS 0-5 (Must have some focal neurological deficit attributable to the target occlusion if NIHSS 0)
- Complete occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA)
- Medium/Distal Vessel Occlusion:
- Visualized complete occlusion or perfusion deficit (Tmax \> 4s) supportive of a cortical branch occlusion in one of the following vessels:
- i) Non-dominant/Co-dominant M2 (defined as serving \< 50% of entire overall MCA territory) ii) M3
- If symptom onset is \> 6h, the core must be less than 50% of the territory supplied by the occluded vessel as evident by either:
- i) Hypodensity and loss of grey-white border on NCCT or ii)ADC \<620 mm2/s on diffusion MRI or rCBF\<30% on CTP
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Berry Consultantscollaborator
- The Cooper Health Systemcollaborator
- University of Pittsburgh Medical Centercollaborator
- Stony Brook Universitycollaborator
- University at Buffalocollaborator
- Medical University of South Carolinalead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- University of Cincinnaticollaborator
- University of Virginiacollaborator
- University of California, Los Angelescollaborator
- MOUNT SINAI HOSPITALcollaborator
Study Sites (41)
University of Alabama Hospital
Birmingham, Alabama, 35294, United States
UCSD Health La Jolla
La Jolla, California, 92093, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California, 92103, United States
Stanford University Medical Center
Stanford, California, 94304, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Yale New Haven Hospital
New Haven, Connecticut, 06511, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
M Health Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
NYU Langone Hospital
Brooklyn, New York, 11220, United States
Buffalo General Medical Center
Buffalo, New York, 14203, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Carolinas Medical Center
Charlotte, North Carolina, 28207, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
OSU Wexner Medical Center
Columbus, Ohio, 43210, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, 15243, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, 29425, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
Medical City Plano
Plano, Texas, 75075, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
University of Utah Healthcare
Salt Lake City, Utah, 84132, United States
UVA Medical Center
Charlottesville, Virginia, 22903, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (2)
Seners P, Cereda CW. Thrombectomy in Stroke With a Large Vessel Occlusion and Mild Symptoms: "Striving to Better, Oft We Mar What's Well?". Stroke. 2023 Sep;54(9):2276-2278. doi: 10.1161/STROKEAHA.123.044205. Epub 2023 Aug 1. No abstract available.
PMID: 37526012DERIVEDFeil K, Matusevicius M, Herzberg M, Tiedt S, Kupper C, Wischmann J, Schonecker S, Mengel A, Sartor-Pfeiffer J, Berger K, Dimitriadis K, Liebig T, Dieterich M, Mazya M, Ahmed N, Kellert L. Minor stroke in large vessel occlusion: A matched analysis of patients from the German Stroke Registry-Endovascular Treatment (GSR-ET) and patients from the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register (SITS-ISTR). Eur J Neurol. 2022 Jun;29(6):1619-1629. doi: 10.1111/ene.15272. Epub 2022 Feb 19.
PMID: 35122371DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordan J Elm, PhD
Medical University of South Carolina
- PRINCIPAL INVESTIGATOR
Eva A Mistry, MBBS, MSCI
University of Cincinnati
- PRINCIPAL INVESTIGATOR
Pooja Khatri, MD
University of Cincinnati
- PRINCIPAL INVESTIGATOR
Colin P Derdeyn, MD
University of Virginia
- PRINCIPAL INVESTIGATOR
Jeffery L Saver, MD
University of California, Los Angeles
- PRINCIPAL INVESTIGATOR
Tudor G Jovin, MD
The Cooper Health System
- PRINCIPAL INVESTIGATOR
Raul G Nogueira, MD, FAHA
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
David Fiorella, MD, PhD
Stony Brook University
- PRINCIPAL INVESTIGATOR
Adnan Siddiqui, MD, PhD
University at Buffalo
- PRINCIPAL INVESTIGATOR
J Mocco, MD, MS
MOUNT SINAI HOSPITAL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor-Faculty
Study Record Dates
First Submitted
February 13, 2024
First Posted
March 4, 2024
Study Start
January 31, 2025
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
January 31, 2030
Last Updated
December 4, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- One year after study is completed.
- Access Criteria
- NIH/NINDS website
De-identified participant-level case report form data will be made available for research purposes upon completion of the trial. Low incidence values and free text fields will be collapsed or removed to ensure participant confidentiality.